Neuromyelitis optica spectrum disorder (NMOSD) is one common demyelinating disease of the central nervous system in young adults, with high rate of disability and recurrence, and poor natural course, which can cause a serious burden on families and society. To today, there is still a lack of prospective, multi-center, large sample clinical trial evidence for the treatment and prognosis of acute attack of NMOSD patients. This study will conduct a prospective, multi-center, single-blind, randomized controlled clinical trial of acute attacked NMOSD patients in China. The researchers plan to collect 144 NMOSD patients with acute attack in three research centers of Guangzhou (the Third Affiliated Hospital of Sun Yat-sen University, the Zhongshan Ophthalmic Center of Sun Yat-sen University, and the Guangdong 999 Brain hospital), to study the safety and efficacy of immunoadsorption therapy. The subjects will be randomized into immunoadsorption group and plasma exchange group, and the following indicators will be evaluated: (1) changes in EDSS scores and visual acuity before and after treatment; (2) changes in AQP4-IgG levels; (3) the safety of immunoadsorption treatment. This study is aimed to determine the efficacy and safety of immunoadsorption therapy for acute attack of refractory NMOSD patients, and to provide more sufficient clinical evidence for the therapy selection for acute phase of NMOSD patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
144
The subjects enrolled in this study will undergo blood purification treatment, and will be randomized into either immunoadsorption group or plasma exchange group, and the following indicators will be evaluated: (1) changes in EDSS scores and visual acuity before and after treatment; (2) changes in AQP4-IgG levels; (3) the safety of immunoadsorption treatment.
Changes in EDSS scores
Changes in EDSS scores of 4 weeks after the last treatment of plasma exchange or immunoadsorption compared with the first treatment
Time frame: 4 weeks after the last treatment vs.baseline ( first treatment)
Comparison of follow-up results of EDSS scores
Comparation of the changes in EDSS scores of the next day, 1 week, 2 weeks, 3 months after the last plasmapheresis or immunoadsorption treatment vs. that before the first treatment
Time frame: the next 1 day, 1 week, 2 weeks, 3 months after the last treatment vs. baseline (that of the time before first treatment)
Comparison of follow-up results of LogMAR
Comparation of the changes in LogMAR of the next day, 1 week, 2 weeks, 3 months after the last plasmapheresis or immunoadsorption treatment vs. that before the first treatment (NMO patients)
Time frame: the next 1 day, 1 week, 2 weeks, 3 months after the last treatment vs. baseline (that of the time before first treatment)
Comparison of follow-up results of AQP4-IgG level
Comparation of the changes in AQP4-IgG level of the next day, 1 week, 2 weeks, 3 months after the last plasmapheresis or immunoadsorption treatment vs. that before the first treatment
Time frame: the next 1 day, 1 week, 2 weeks, 3 months after the last treatment vs. baseline (that of the time before first treatment)
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